Crohn Disease Clinical Trial
— FACCOfficial title:
A National, Multicenter, Randomized Open-Label Study of Proctological Surgery Efficacy on Anoperineal Fistulas Healing in Crohn's Disease Patients Treated With Adalimumab. (Official French Title: "Étude Nationale, Multicentrique, randomisée et en Ouvert de l'efficacité de la Chirurgie Proctologique Sur la Cicatrisation Des Fistules anopérinéales de la Maladie de Crohn Chez Des Patients traités Par Adalimumab")
The purpose of this study is to demonstrate, in patients treated with adalimumab, the efficacy of proctological surgery in anoperineal fistula healing after the removal of seton drain.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | March 2017 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - male or female 18 years or older, - women of childbearing age who use an effective contraception method or women incapable of becoming pregnant [(i.e. postmenopausal women for 1 year or surgically sterile (hysterectomy and/or bilateral oophorectomy)], - Patient with fistulizing anoperineal Crohn's disease. Anoperineal fistulas can be associated with ileal, colic or rectal lesions, - Patient with at least 1 anoperineal fistula drained with a seton for more than 1 month, - Patient treated with adalimumab for more than 1 month, - Patient who agrees to undergo surgery for its drained fistula(s), - Patient with immunosuppressive therapy (azathioprine, 6-mercaptopurine ou methotrexate) stable for at least 3 months or patients without immunosuppressive therapy, - Patient who gave signed written informed consent after having received verbal explanation and written information related to the trial. Exclusion Criteria: - Pregnant or breastfeeding women, - Patient having a perineal abscess, - Patient with a high anovaginal fistula that cannot be treated, according to the investigator ,with fistulotomy, gluing, biodegradable plug or advancement flap, - Patient treated with a daily dose of corticosteroids of more than 20 mg (a dose of more than 20 mg daily will be authorized during the study), - Contraindication to proctological surgery on the drained fistula(s), - Patient presenting with somatic or psychic signs or symptoms that are not compatible with his/her participation in the trial according to the investigator, - Patient who participate in another clinical trial. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Polyclinique de Franche-Comté - Department of Proctological Surgery | Besançon | Franche-Comté |
France | CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology | Bordeaux | Aquitaine |
France | Hôpital Louis Mourier - Department of Hepato-Gastroentérologie | Colombes | Ile-de-France |
France | Clinique des Cèdres - Hepato-Gastroenterology Department | Cornebarrieu | Midi-Pyrénées |
France | Clinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery Unit | Grenoble | Rhône-Alpes |
France | Hôpital Nord de Marseille - Gastroenterology Department | Marseille | |
France | Hôpital Bichat-Claude Bernard - Gastro-enterology Department | Paris | Ile-de-France |
France | Institut de Proctologie Léopold Bellan - Groupe Hospitalier Paris Saint Joseph - Department of Colo-Proctology | Paris | Ile-de-France |
France | Institut Mutualiste Montsouris - Proctology Unit | Paris | Ile-de-France |
France | Hôpital de POISSY | Poissy | |
France | CHU Pontchaillou - Department of Digestive Diseases | Rennes | Bretagne |
France | CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition | Rouen | Haute Normandie |
France | Polyclinique de l'Océan | Saint-Nazaire | |
France | Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology | Talence | Aquitaine |
France | Clinique Saint Jean Languedoc - Department of Gastroenterology | Toulouse | Midi-Pyrénées |
Lead Sponsor | Collaborator |
---|---|
French Society of Coloproctology |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients having a clinical healing of their anoperineal fistulas in Crohn disease | 12 months after seton drain removal | No | |
Secondary | Proportion of patients having more than half of their fistulas healed | 3, 6, 12 and 24 months after seton drain removal | No | |
Secondary | Change in Crohn disease activity assessed by Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI) | 3, 6, 12 and 24 months after seton drain removal | No | |
Secondary | Change in anal continence assessed by Wexner and Vaizey scores | 12 and 24 months after seton drain removal | No | |
Secondary | Crohn's Disease Endoscopic Index of Severity (CDEIS) | 12 months after seton drain removal | No | |
Secondary | Change in patients' quality of life, assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) | 12 and 24 months after seton drain removal | No | |
Secondary | Change in fistula activity assessed by magnetic resonance imaging (MRI) | Change in fistula activity assessed by MRI (Van Assche score and absence of contrast enhancement after injection of gadolinium with regards to fistulous tract | 6, 12 and 24 months after seton drain removal | No |
Secondary | Change in discomfort and impact assessed by the patient using a visual analog scale (VAS) | 3, 6, 12 and 24 months after seton drain removal | No |
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